Phase 1 Study of Oral TP-1454
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|ClinicalTrials.gov Identifier: NCT04328740|
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: TP-1454 monotherapy Drug: TP-1454 combination therapy||Phase 1|
- To establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors a monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy
- To establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors
- To establish the pharmacokinetic (PK) profile of orally administered TP-1454 alone and in combination with ipilimumab and nivolumab
- To observe patients for any evidence of antitumor activity of TP 1454 alone and in combination with ipilimumab and nivolumab by objective radiographic assessment
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1454 Alone and in Combination With Ipilimumab and Nivolumab|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||December 2022|
Drug: TP-1454 monotherapy
Flat dose once daily, alone
Experimental: Combination Therapy
TP-1454, ipilimumab and nivolumab
Drug: TP-1454 combination therapy
Flat dose once daily, in combination with ipilimumab and nivolumab
- Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 months ]A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days of treatment.
- Determine maximum tolerated dose (MTD) [ Time Frame: 28 months ]MTD will be determined based upon toxicity grades which are defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
- Recommended Ph 2 dose of TP-1454 [ Time Frame: 28 months ]To establish the recommended Ph 2 dose (RP2D) for future studies with TP-1454. MTD data to be reviewed.
- Determine antitumor activity of TP-1454. [ Time Frame: 28 months ]Objective radiographic assessment to be performed to determine antitumor activity by Response Evaluation Criteria in Solid Tumors (RECIST criteria v 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328740
|Contact: Holly Beever, RNfirstname.lastname@example.org|
|Contact: Susan Smith, MSN||210-414-7702|
|United States, Nevada|
|Comprehensive Cancer Center of Nevada|
|Las Vegas, Nevada, United States, 89169|
|Contact: Nicholas Vogelzang, MD|
|Principal Investigator: Nicholas Vogelzang, MD|
|Study Director:||Stephen Anthony, DO||Tolero Pharmaceuticals|